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Cardiac Surgery

RCT: Transcatheter Edge-to-edge Repair Improves Outcomes in Severe Tricuspid Regurgitation

29 Nov, 2024 | 12:37h | UTC

Background: Severe tricuspid regurgitation (TR) is linked to poor quality of life and increased mortality. Traditional medical therapy offers limited symptom relief, and surgical options carry high risks. Transcatheter tricuspid valve therapies like transcatheter edge-to-edge repair (T-TEER) have emerged as less invasive alternatives, but their impact on patient outcomes needs further exploration.

Objective: To determine if T-TEER combined with optimized medical therapy (OMT) enhances patient-reported outcomes and clinical events compared to OMT alone in patients with severe, symptomatic TR.

Methods: In this multicenter, prospective, randomized (1:1) trial, 300 adults with severe, symptomatic TR despite stable OMT were enrolled from 24 centers in France and Belgium between March 2021 and March 2023. Participants were randomized to receive either T-TEER plus OMT or OMT alone. The primary outcome was a composite clinical endpoint at 1 year, including changes in New York Heart Association (NYHA) class, patient global assessment (PGA), or occurrence of major cardiovascular events. Secondary outcomes encompassed TR severity, Kansas City Cardiomyopathy Questionnaire (KCCQ) score, and a composite of death, tricuspid valve surgery, KCCQ improvement, or hospitalization for heart failure.

Results: At 1 year, 74.1% of patients in the T-TEER plus OMT group improved in the composite endpoint versus 40.6% in the OMT-alone group (P < .001). Massive or torrential TR persisted in 6.8% of the T-TEER group compared to 53.5% of the OMT group (P < .001). The mean KCCQ score was higher in the T-TEER group (69.9 vs 55.4; P < .001). The win ratio for the composite secondary outcome was 2.06 (95% CI, 1.38-3.08; P < .001). No significant differences were observed in major cardiovascular events or cardiovascular death between groups.

Conclusions: Adding T-TEER to OMT significantly reduces TR severity and improves patient-reported outcomes at 1 year in patients with severe, symptomatic TR, without increasing adverse events.

Implications for Practice: T-TEER may offer a valuable addition to OMT for selected patients with severe TR, enhancing symptoms and quality of life. However, the absence of significant differences in hard clinical endpoints and the open-label design suggest cautious interpretation. Clinicians should weigh the benefits against potential biases in patient-reported outcomes.

Study Strengths and Limitations: Strengths include the randomized design and multicenter participation, enhancing the study’s validity. Limitations involve the open-label design without a sham control, potentially introducing bias in subjective outcomes. The short follow-up period and selective patient population based on anatomical suitability for T-TEER may limit generalizability.

Future Research: Longer-term studies are necessary to assess T-TEER’s impact on survival and heart failure hospitalization. Comparative studies of different transcatheter devices and investigations into optimal patient selection criteria are also recommended.

Reference: Donal E, Dreyfus J, Leurent G, et al. Transcatheter Edge-to-Edge Repair for Severe Isolated Tricuspid Regurgitation: The Tri.Fr Randomized Clinical Trial. JAMA. Published online November 27, 2024. DOI: http://doi.org/10.1001/jama.2024.21189

 


News Release: Edoxaban Comparable to Warfarin for Stroke Prevention After Bioprosthetic Valve Surgery

20 Nov, 2024 | 20:05h | UTC

Introduction: A recent multicenter trial from Japan, presented at the American Heart Association’s Scientific Sessions 2024, has found that edoxaban, a direct oral anticoagulant, is as effective as warfarin in preventing stroke and systemic embolism in patients following bioprosthetic heart valve replacement surgery. This addresses the ongoing need for alternative anticoagulant therapies that simplify post-surgical management and enhance patient quality of life.

Highlights: The ENBALV trial enrolled approximately 400 adults aged 41 to 84 who underwent bioprosthetic valve replacement at the aortic and/or mitral position. Participants were randomly assigned to receive either edoxaban (60 mg or 30 mg once daily) or warfarin for 12 weeks post-surgery. Unlike warfarin, edoxaban does not require regular blood tests to monitor clotting activity and has fewer interactions with food and other medications.

Key findings include:

  • Efficacy: Stroke or systemic embolism occurred in 0.5% of patients receiving edoxaban compared to 1.5% in the warfarin group, indicating comparable effectiveness.
  • Thrombus Formation: No intracardiac thrombus was observed in the edoxaban group, whereas it occurred in 1% of patients on warfarin.
  • Bleeding Risks: Major bleeding events were higher in the edoxaban group (4.1% vs. 1% with warfarin). While no fatal bleeding or intracranial hemorrhage occurred with edoxaban, one fatal cerebral hemorrhage was reported in the warfarin group. Gastrointestinal bleeding was more common with edoxaban (2.1% vs. 0% with warfarin).

Lead author Dr. Chisato Izumi noted that edoxaban’s fixed dosing and minimal dietary interactions reduce the treatment burden, potentially improving patient adherence during the critical post-operative period.

Conclusion: The findings suggest that edoxaban is a viable alternative to warfarin for anticoagulation after bioprosthetic valve surgery, offering similar protection against stroke and blood clots with the convenience of simplified management. However, the increased incidence of bleeding events with edoxaban underscores the need for careful patient selection and further research to identify individuals at higher risk. These results may inform future clinical guidelines and improve patient care by providing more flexible anticoagulant options.

Source: This study was conducted by the National Cerebral and Cardiovascular Center in Suita, Japan, and presented at the American Heart Association’s Scientific Sessions 2024. The full news release is available at: http://newsroom.heart.org/news/patients-taking-edoxoban-after-heart-valve-surgery-had-lower-risk-of-stroke-blood-clots

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Cohort Study: High Rate of Preventable Adverse Events in Surgical Inpatients

16 Nov, 2024 | 17:29h | UTC

Background: Adverse events during hospital admissions, particularly in surgical settings, remain a significant cause of patient harm despite efforts to improve patient safety since the “To Err is Human” report. Advances in surgical techniques and patient care necessitate an updated assessment of the current state of perioperative safety.

Objective: To estimate the frequency, severity, and preventability of adverse events associated with perioperative care in surgical inpatients and to identify the settings and healthcare professionals involved.

Methods: A multicenter retrospective cohort study was conducted across 11 US hospitals in Massachusetts. A weighted random sample of 1,009 patients was selected from 64,121 adults admitted for surgery in 2018. Trained nurses reviewed electronic health records to identify adverse events, which were then adjudicated by physicians. Adverse events were classified by type, severity, preventability, setting, and professions involved.

Results: Adverse events occurred in 38.0% of patients (95% CI, 32.6–43.4%), with major adverse events in 15.9% (12.7–19.0%). Among 593 adverse events identified, 59.5% were potentially preventable, and 20.7% were definitely or probably preventable. The most common events were surgery-related (49.3%), adverse drug events (26.6%), healthcare-associated infections (12.4%), and patient care events (11.2%). Adverse events most frequently occurred in general care units (48.8%) and involved attending physicians (89.5%) and nurses (58.9%).

Conclusions: More than one-third of surgical inpatients experienced adverse events, with nearly half classified as major and most potentially preventable. These findings highlight the critical need for ongoing improvement in patient safety throughout perioperative care involving all healthcare professionals.

Implications for Practice: Healthcare providers should enhance patient safety protocols across all perioperative settings, not just in operating rooms. Emphasis should be placed on preventing surgery-related complications, adverse drug events, and healthcare-associated infections by fostering teamwork and continuous monitoring.

Study Strengths and Limitations: Strengths include a comprehensive review of medical records and systematic classification of adverse events by trained professionals. Limitations involve the study’s confinement to Massachusetts hospitals in 2018, potential variability in documentation practices, and limited sample size affecting generalizability and specialty-specific estimates.

Future Research: Further studies are needed to assess adverse event rates in diverse geographic locations and healthcare systems, explore effective interventions to reduce preventable harm, and evaluate long-term trends in surgical patient safety.

Reference: Duclos A, Frits ML, Iannaccone C, Lipsitz SR, Cooper Z, Weissman JS, Bates DW. Safety of inpatient care in surgical settings: cohort study. BMJ. 2024; DOI: http://doi.org/10.1136/bmj-2024-080480

 


RCT: Preemptive TAVR Does Not Improve Composite Outcomes but May Improve Quality of Life in HFrEF Patients with Moderate Aortic Stenosis

10 Nov, 2024 | 14:18h | UTC

Background: Heart failure with reduced ejection fraction (HFrEF) management emphasizes neurohormonal modulation and afterload reduction. Moderate aortic stenosis (AS) increases afterload, potentially worsening outcomes in HFrEF patients. While transcatheter aortic valve replacement (TAVR) is established for severe AS, its benefit in moderate AS remains uncertain.

Objective: To determine whether TAVR provides clinical benefits over guideline-directed medical therapy (GDMT) in patients with HFrEF and moderate AS.

Methods: In the TAVR UNLOAD randomized controlled trial, 178 symptomatic HFrEF patients (left ventricular ejection fraction 20%-50%) on GDMT with moderate AS were randomized 1:1 to receive TAVR with a balloon-expandable valve or clinical AS surveillance (CASS) with aortic valve replacement upon progression to severe AS. The primary endpoint was the hierarchical occurrence of: (1) all-cause death; (2) disabling stroke; (3) disease-related hospitalizations and heart failure equivalents; and (4) change from baseline in the Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OSS).

Results: The mean age was 77 years, 20.8% were female, and 55.6% were in NYHA class III or IV. Median follow-up was 23 months. In the CASS group, 43% underwent TAVR due to progression to severe AS at a median of 12 months. TAVR was not superior to CASS for the primary endpoint (win ratio 1.31; 95% CI: 0.91-1.88; P = 0.14). However, at 1 year, TAVR resulted in a greater improvement in KCCQ-OSS compared with CASS (12.8 ± 21.9 vs 3.2 ± 22.8 points; P = 0.018). There were no significant differences in all-cause mortality or major adverse events between groups.

Conclusions: In HFrEF patients with moderate AS on GDMT, TAVR was not superior to clinical surveillance for the primary composite endpoint but was associated with improved quality of life at 1 year.

Implications for Practice: Preemptive TAVR may offer quality-of-life benefits in select symptomatic HFrEF patients with moderate AS but does not reduce mortality or major cardiovascular events compared to surveillance. Clinicians should weigh patient-specific factors when considering TAVR for moderate AS.

Study Strengths and Limitations: Strengths include being the first randomized trial assessing TAVR in moderate AS with HFrEF. Limitations involve being underpowered due to slow enrollment and protocol changes, and a high crossover rate (43% in the CASS group underwent TAVR), potentially attenuating differences between groups.

Future Research: Larger, adequately powered trials are needed to confirm these findings and identify patients who may benefit most from preemptive TAVR in moderate AS.

Reference: Van Mieghem NM, Elmariah S, Spitzer E, et al. Transcatheter Aortic Valve Replacement in Patients With Systolic Heart Failure and Moderate Aortic Stenosis: TAVR UNLOAD. Journal of the American College of Cardiology. 2024 Oct 28. DOI: http://doi.org/10.1016/j.jacc.2024.10.070

 


RCT: Transcatheter Tricuspid-Valve Replacement Improves Symptoms and Quality of Life in Severe Tricuspid Regurgitation

3 Nov, 2024 | 12:37h | UTC

Background: Severe tricuspid regurgitation is associated with debilitating symptoms and increased mortality. Surgical intervention is infrequently performed due to high operative risks and late patient presentation, leading to poor outcomes. Transcatheter tricuspid-valve replacement offers a less invasive alternative versus surgical intervention, but data on its efficacy are limited.

Objective: To compare the safety and effectiveness of transcatheter tricuspid-valve replacement plus medical therapy versus medical therapy alone in patients with severe symptomatic tricuspid regurgitation.

Methods: In this international, multicenter randomized controlled trial, 400 patients with severe symptomatic tricuspid regurgitation despite optimal medical therapy were randomized in a 2:1 ratio to receive transcatheter tricuspid-valve replacement plus medical therapy (valve-replacement group, n=267) or medical therapy alone (control group, n=133). The primary outcome was a hierarchical composite of death from any cause, implantation of a right ventricular assist device or heart transplantation, postindex tricuspid-valve intervention, hospitalization for heart failure, and improvements in the KCCQ-OS score by at least 10 points, NYHA functional class by at least one class, and 6-minute walk distance by at least 30 meters.

Results: At one year, the win ratio favoring valve replacement was 2.02 (95% confidence interval [CI], 1.56 to 2.62; P<0.001), indicating superiority over medical therapy alone. Patients in the valve-replacement group had significant improvements in quality of life, with 66.4% achieving an increase of at least 10 points in the KCCQ-OS score compared to 36.5% in the control group. Improvement of at least one NYHA class was observed in 78.9% of the valve-replacement group versus 24.0% of the control group. Reduction of tricuspid regurgitation to mild or less was achieved in 95.2% of patients in the valve-replacement group, compared to 2.3% in the control group. Severe bleeding occurred more frequently in the valve-replacement group (15.4% vs. 5.3%; P=0.003), as did new permanent pacemaker implantation (17.8% vs. 2.3%; P<0.001).

Conclusions: Transcatheter tricuspid-valve replacement significantly improved clinical outcomes, symptoms, functional capacity, and quality of life in patients with severe tricuspid regurgitation compared to medical therapy alone, despite higher risks of severe bleeding and pacemaker implantation.

Implications for Practice: Transcatheter tricuspid-valve replacement offers a promising therapeutic option for patients with severe symptomatic tricuspid regurgitation who are at high surgical risk. Clinicians should consider this intervention to improve patient symptoms and quality of life, while carefully weighing the procedural risks, particularly bleeding and arrhythmias requiring pacemaker implantation.

Study Strengths and Limitations: Strengths of the study include its randomized controlled design and comprehensive evaluation of both clinical and patient-reported outcomes. Limitations involve the smaller control group due to the 2:1 randomization and a one-year follow-up period that may not capture long-term benefits or risks.

Future Research: Further studies with longer follow-up are needed to assess the durability of transcatheter tricuspid-valve replacement, its long-term impact on survival and hospitalization rates, and strategies to minimize procedural complications.

Reference: Hahn RT, et al. Transcatheter Valve Replacement in Severe Tricuspid Regurgitation. New England Journal of Medicine. 2024 Oct 30; DOI: http://doi.org/10.1056/NEJMoa2401918

 


RCT: Early TAVR Improves Clinical Outcomes in Asymptomatic Severe Aortic Stenosis

29 Oct, 2024 | 13:04h | UTC

Background: Severe aortic stenosis is prevalent among adults aged 65 and older. Current guidelines recommend aortic-valve replacement for symptomatic patients or asymptomatic patients with specific high-risk features. For other asymptomatic patients, routine clinical surveillance is standard due to limited evidence supporting early intervention, particularly with transcatheter aortic-valve replacement (TAVR).

Objective: To determine whether early TAVR reduces the incidence of death, stroke, or unplanned cardiovascular hospitalization compared to standard clinical surveillance in patients with asymptomatic severe aortic stenosis.

Methods: In this prospective, multicenter, randomized controlled trial, 901 asymptomatic patients aged ≥65 years with severe aortic stenosis and preserved left ventricular ejection fraction were randomized 1:1 to undergo early TAVR or to receive guideline-directed clinical surveillance. The mean age was 75.8 years, and the mean Society of Thoracic Surgeons Predicted Risk of Mortality score was 1.8%, indicating low surgical risk. The primary endpoint was a composite of death from any cause, stroke, or unplanned hospitalization for cardiovascular causes.

Results: Over a median follow-up of 3.8 years, the primary endpoint occurred in 26.8% of the TAVR group compared to 45.3% of the surveillance group (hazard ratio [HR], 0.50; 95% confidence interval [CI], 0.40–0.63; P<0.001). Individual components showed lower rates in the TAVR group: death (8.4% vs. 9.2%), stroke (4.2% vs. 6.7%), and unplanned cardiovascular hospitalizations (20.9% vs. 41.7%). Early TAVR patients also maintained better quality of life, with 86.6% achieving favorable outcomes at 2 years compared to 68.0% in the surveillance group (P<0.001). By 2 years, 87.0% of patients in the surveillance group underwent aortic-valve replacement, many presenting with advanced symptoms and cardiac damage. Procedural complications and periprocedural adverse events were similar between groups.

Conclusions: Early TAVR significantly reduced death, stroke, and unplanned cardiovascular hospitalizations in asymptomatic patients with severe aortic stenosis compared to clinical surveillance. Early intervention preserved quality of life and cardiac function, suggesting that early TAVR may benefit this patient population.

Implications for Practice: These findings support considering early TAVR in asymptomatic patients with severe aortic stenosis to improve clinical outcomes and quality of life. This may challenge current guidelines that recommend surveillance over early intervention.

Study Strengths and Limitations: Strengths include the randomized design, large sample size, and multicenter participation. Limitations involve the study population being predominantly low surgical risk patients aged ≥65 years with anatomy suitable for transfemoral TAVR, which may limit generalizability to younger patients, those with higher surgical risk, or those unsuitable for TAVR.

Future Research: Further research is needed to assess long-term valve durability, outcomes in diverse patient populations, and comparisons with surgical aortic-valve replacement. Studies on cost-effectiveness and the impact on guidelines are also warranted.

Reference: Généreux P, et al. Transcatheter Aortic-Valve Replacement for Asymptomatic Severe Aortic Stenosis. New England Journal of Medicine. 2024 Oct 28; DOI: http://doi.org/10.1056/NEJMoa2405880

 


RCT: Early Surgical AVR Improved Outcomes in Asymptomatic Severe Aortic Stenosis

6 Oct, 2024 | 16:29h | UTC

Background: Severe aortic stenosis (AS) is a prevalent valvular heart disease requiring intervention in symptomatic patients. The optimal timing for surgical aortic valve replacement (AVR) in truly asymptomatic patients with severe AS and normal left ventricular (LV) systolic function remains uncertain and is under investigation.

Objective: To determine whether early surgical AVR improves clinical outcomes compared to conservative management with watchful waiting in asymptomatic patients with severe AS and normal LV ejection fraction (LVEF ≥50%).

Methods: The AVATAR trial was a multicenter, randomized controlled trial involving 157 low-risk, asymptomatic patients (mean age 67 years, 57% men) with severe AS and normal LVEF. Patients were randomized to early surgical AVR (n=78) or conservative treatment (n=79). All participants had negative exercise stress tests to confirm asymptomatic status. The primary composite endpoint included all-cause death, acute myocardial infarction, stroke, or unplanned hospitalization for heart failure (HF). Secondary outcomes encompassed individual components of the primary endpoint, cardiovascular death, serious adverse events, and procedural metrics.

Results: Over a median follow-up of 63 months, the primary composite endpoint occurred in 23.1% of the early surgery group versus 46.8% of the conservative group (hazard ratio [HR] 0.42; 95% confidence interval [CI], 0.24–0.73; P=0.002). All-cause mortality was significantly lower in the early surgery group (16.7% vs. 34.2%; HR 0.44; 95% CI, 0.23–0.85; P=0.012). Unplanned HF hospitalizations were also reduced (4.0% vs. 17.0%; HR 0.21; 95% CI, 0.06–0.73; P=0.007). There were no significant differences in stroke rates between the groups. Serious adverse events occurred less frequently in the early surgery group (26.4% vs. 49.4%; P=0.013). Sudden cardiac death was less common in the early surgery group, though not statistically significant (5.1% vs. 11.4%; P=0.17).

Conclusions: Early surgical AVR in asymptomatic patients with severe AS and normal LVEF significantly improved clinical outcomes, including reductions in all-cause mortality and HF hospitalizations, compared to conservative management.

Implications for Practice: These findings support considering early surgical AVR in truly asymptomatic patients with severe AS and normal LV function to reduce the risk of adverse events and improve long-term outcomes. Clinicians should weigh the benefits of early intervention against surgical risks, emphasizing careful patient selection and monitoring.

Study Strengths and Limitations: Strengths of the study include its randomized design, extended follow-up period, and strict inclusion of truly asymptomatic patients confirmed by negative exercise testing. Limitations involve a smaller sample size than initially projected, potential impacts of the COVID-19 pandemic on follow-up and healthcare access, and early termination of enrollment, which may affect the generalizability of the results.

Future Research: Further large-scale randomized trials are needed to validate these findings and explore the role of early intervention strategies, including transcatheter aortic valve implantation (TAVI), in asymptomatic patients with severe AS.

Reference: Banovic M, et al. (2024). Aortic Valve Replacement vs. Conservative Treatment in Asymptomatic Severe Aortic Stenosis: Long-Term Follow-Up of the AVATAR Trial. European Heart Journal. DOI: https://doi.org/10.1093/eurheartj/ehae585

 


Meta-analysis: Perioperative Colchicine Reduced Postoperative Atrial Fibrillation After CABG

18 Sep, 2024 | 13:33h | UTC

Background: Coronary artery disease (CAD) remains a leading cause of mortality worldwide. Inflammation is a key factor in the development and progression of CAD, and anti-inflammatory therapies have shown potential in improving cardiovascular outcomes. Colchicine, traditionally used to treat gout, has demonstrated efficacy in reducing cardiovascular events in patients with chronic CAD. Previous individual studies have suggested that perioperative colchicine may decrease the incidence of postoperative atrial fibrillation (POAF) in patients undergoing coronary artery bypass grafting (CABG), but a comprehensive analysis is needed to confirm these findings.

Objective: To evaluate the effect of perioperative colchicine administration on the incidence of POAF in patients undergoing isolated CABG surgery through a meta-analysis of randomized controlled trials (RCTs).

Methods: A systematic search was conducted across MEDLINE, Web of Science, and The Cochrane Library to identify RCTs comparing perioperative colchicine administration with standard care in patients undergoing CABG. Inclusion criteria encompassed studies involving isolated CABG patients randomized to receive colchicine or standard care without colchicine. The primary outcome was the incidence of POAF during short-term follow-up.

Results: Five RCTs published between 2014 and 2022 met the inclusion criteria, including a total of 839 patients undergoing isolated CABG. Perioperative colchicine administration was associated with a significant reduction in POAF rates compared to standard care (relative risk [RR], 0.54; 95% confidence interval [CI], 0.40–0.73; p < 0.01). Other outcomes, such as graft patency, myocardial infarction, or long-term mortality, were not uniformly reported and, therefore, not analyzed.

Conclusions: Perioperative administration of colchicine is associated with a significant reduction in the incidence of POAF in patients undergoing CABG surgery.

Implications for Practice: Colchicine may be considered as a prophylactic strategy to reduce POAF in patients undergoing CABG, potentially improving both short- and long-term outcomes. Given the association of POAF with increased perioperative morbidity and long-term adverse events, implementing colchicine could have substantial clinical benefits in this high-risk population.

Study Strengths and Limitations: Strengths of this meta-analysis include the exclusive inclusion of randomized controlled trials and the use of rigorous statistical methods, including sensitivity analysis, which confirmed the robustness of the results. Limitations involve the small number of studies (five RCTs), potential variability in colchicine dosing regimens, and the lack of data on other clinically relevant outcomes.

Future Research: Large-scale, multicenter RCTs are warranted to further assess the effects of colchicine on other important outcomes in CABG patients, such as graft patency, myocardial infarction rates, and long-term mortality. Future studies should also evaluate the risk-benefit profile of colchicine in this patient population to establish its full role in clinical practice.

Reference: Kirov H., Caldonazo T., Runkel A., et al. (2024). Colchicine in Patients with Coronary Disease Undergoing Coronary Artery Bypass Surgery – A Meta-Analysis of Randomized Controlled Trials. The American Journal of Cardiology. DOI: http://doi.org/10.1016/j.amjcard.2024.09.003

 


RCT: Transcatheter Repair Noninferior to Mitral-Valve Surgery for Secondary Mitral Regurgitation

12 Sep, 2024 | 12:13h | UTC

Study Design and Population: This noninferiority trial, conducted in Germany, enrolled 210 patients with heart failure and secondary mitral regurgitation who remained symptomatic despite medical therapy. Patients were randomized to undergo either transcatheter edge-to-edge repair or mitral-valve surgery, with outcomes assessed over a one-year period.

Main Findings: Transcatheter repair was found to be noninferior to mitral-valve surgery regarding the primary efficacy outcome—a composite of death, heart failure hospitalization, mitral-valve reintervention, assist device implantation, or stroke at one year (16.7% in the transcatheter group vs. 22.5% in the surgery group; mean difference, -6%; 95% CI, -17 to 6; P<0.001 for noninferiority). The transcatheter group experienced fewer major adverse events within 30 days (14.9% vs. 54.8%; mean difference, -40%; 95% CI, -51 to -27; P<0.001).

Implications for Practice: Transcatheter edge-to-edge repair offers a similar efficacy to mitral-valve surgery at one year with a lower rate of short-term adverse events, suggesting it may be a suitable alternative, particularly for patients with higher surgical risk.

Reference: Baldus, S. et al. (2024). Transcatheter repair versus mitral-valve surgery for secondary mitral regurgitation. New England Journal of Medicine. DOI: http://doi.org/10.1056/NEJMoa2408739

 


2024 ESC Guidelines for the Management of Chronic Coronary Syndromes

1 Sep, 2024 | 18:49h | UTC

Introduction: The 2024 guidelines were developed by the European Society of Cardiology (ESC) with the endorsement of the European Association for Cardio-Thoracic Surgery (EACTS). These guidelines provide updated recommendations for the management of chronic coronary syndromes (CCS), focusing on the diagnosis, treatment, and long-term care of patients with stable coronary artery disease (CAD).

 

Key Points:

1 – History and Risk Assessment:

– Detailed assessment of cardiovascular risk factors, medical history, and symptom characteristics is essential in patients with suspected CCS.

– Symptoms like chest pain triggered by emotional stress, dyspnea on exertion, or fatigue should be considered potential angina equivalents.

 

2 – Diagnostic Testing:

– Coronary Computed Tomography Angiography (CCTA): Recommended as a first-line diagnostic tool for patients with low to moderate pre-test likelihood of obstructive CAD.

– Stress Imaging: Stress echocardiography, SPECT, PET, or cardiac MRI is recommended for those with moderate to high pre-test likelihood to diagnose myocardial ischemia and estimate the risk of major adverse cardiovascular events (MACE).

 

3 – Revascularization Indications:

– Symptom Relief: Revascularization is recommended for patients with obstructive CAD who have significant symptoms despite optimal medical therapy.

– Prognostic Benefit: Indicated in patients with left main coronary artery disease, severe three-vessel disease, or two-vessel disease including proximal left anterior descending artery stenosis, particularly if associated with reduced left ventricular function.

– High-Risk Anatomical Features: Revascularization is advised when significant stenosis is present in patients with high-risk anatomical features identified by imaging, especially if non-invasive testing shows a large area of ischemia.

 

4 – Lifestyle and Risk Management:

– A comprehensive approach to cardiovascular risk reduction, including lifestyle changes (e.g., smoking cessation, diet, and physical activity) and guideline-directed medical therapy, is strongly recommended.

– Home-based cardiac rehabilitation and digital health interventions are suggested to improve long-term adherence to healthy behaviors.

 

5 – Antianginal and Antithrombotic Therapy:

– Tailoring antianginal therapy based on individual patient characteristics, comorbidities, and local drug availability is recommended.

– Long-term antithrombotic therapy with aspirin or clopidogrel is recommended for patients with prior myocardial infarction or revascularization.

 

Conclusion: The 2024 ESC guidelines emphasize a patient-centered approach, integrating advanced diagnostic tools and personalized therapeutic strategies to optimize outcomes for patients with chronic coronary syndromes. The guidelines highlight the importance of detailed risk assessment, appropriate use of diagnostic imaging, clear criteria for revascularization, and a strong focus on lifestyle interventions alongside pharmacological management.

Reference: European Society of Cardiology (2024). “ESC Guidelines for the management of chronic coronary syndromes.” European Heart Journal. https://doi.org/10.1093/eurheartj/ehae177

 


RCT: Hypothermic Oxygenated Perfusion Trends Toward Lower Primary Graft Dysfunction in Heart Transplantation – The Lancet

17 Aug, 2024 | 19:38h | UTC

Study Design and Population: This randomized, controlled, open-label, multicenter clinical trial evaluated the safety and efficacy of hypothermic oxygenated machine perfusion (HOPE) compared to static cold storage (SCS) in preserving donor hearts for transplantation. Conducted across 15 transplant centers in eight European countries, the study enrolled 229 adult heart transplant candidates between November 2020 and May 2023. The trial included 204 patients who received a transplant and met the study’s inclusion and exclusion criteria.

Main Findings: The primary composite endpoint, including cardiac-related death, graft dysfunction, and rejection within 30 days post-transplant, occurred in 19% of patients in the HOPE group compared to 30% in the SCS group, reflecting a 44% risk reduction (HR 0.56, 95% CI 0.32–0.99, p=0.059). Notably, primary graft dysfunction was significantly lower in the HOPE group (11% vs. 28%, RR 0.39, 95% CI 0.20–0.73). The incidence of major adverse cardiac transplant events was also reduced with HOPE (18% vs. 32%, RR 0.56, 95% CI 0.34–0.92).

Implications for Practice: HOPE showed a potential clinical benefit by reducing the incidence of primary graft dysfunction and major adverse cardiac events after heart transplantation. Although the primary endpoint was not statistically significant, the observed risk reductions suggest that HOPE could improve outcomes in heart transplantation. Further research is needed to confirm these findings and optimize donor heart preservation strategies.

Reference: Rega, F., Lebreton, G., Para, M., Michel, S., Schramm, R., Begot, E., et al. (2024). Hypothermic oxygenated perfusion of the donor heart in heart transplantation: the short-term outcome from a randomised, controlled, open-label, multicentre clinical trial. The Lancet, 404(10453), 670-682. DOI: https://doi.org/10.1016/S0140-6736(24)01078-X.

 


RCT: Intravenous Amino Acids Reduce AKI Incidence in Cardiac Surgery Patients – N Engl J Med

3 Aug, 2024 | 19:12h | UTC

Study Design and Population: In this multinational, double-blind, randomized clinical trial, 3511 adult patients scheduled for cardiac surgery with cardiopulmonary bypass were recruited from 22 centers across three countries. Patients were randomly assigned to receive an intravenous infusion of either a balanced mixture of amino acids (2 g/kg/day) or a placebo (Ringer’s solution) for up to three days.

Main Findings: The primary outcome, occurrence of acute kidney injury (AKI), was significantly lower in the amino acid group (26.9%) compared to the placebo group (31.7%) with a relative risk of 0.85 (95% CI, 0.77 to 0.94; P=0.002). The incidence of severe AKI (stage 3) was also reduced in the amino acid group (1.6% vs. 3.0%; relative risk, 0.56; 95% CI, 0.35 to 0.87). There were no substantial differences between the groups regarding secondary outcomes such as the use and duration of kidney-replacement therapy or all-cause 30-day mortality.

Implications for Practice: The infusion of amino acids in adult patients undergoing cardiac surgery appears to reduce the incidence of AKI, indicating a potential protective renal effect. However, this intervention did not significantly impact other secondary outcomes, including mortality and the use of kidney-replacement therapy. These findings suggest that amino acids could be considered as a strategy to mitigate AKI risk in this patient population, although further research is needed to explore long-term benefits and other clinical outcomes.

Reference: Landoni G, Monaco F, Ti LK, Baiardo Redaelli M, Bradic N, Comis M, Kotani Y, for the PROTECTION Study Group. (2024). A randomized trial of intravenous amino acids for kidney protection. New England Journal of Medicine, 390(24), 1765-1774. DOI: 10.1056/NEJMoa2403769.


PCI vs. CABG in left main coronary disease patients with and without diabetes—a pooled analysis of 4 trials

22 Mar, 2024 | 11:41h | UTC

Study Design and Population: This research pooled individual patient data from four randomized clinical trials (SYNTAX, PRECOMBAT, NOBLE, and EXCEL), comparing percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) in 4393 patients with left main coronary artery disease. The trials included both patients with and without diabetes, allowing for a comparative analysis of outcomes based on the revascularization method and the presence of diabetes.

Main Findings: Patients with diabetes exhibited higher rates of 5-year mortality, spontaneous myocardial infarction (MI), and repeat revascularization compared to those without diabetes. However, mortality rates following PCI vs. CABG were similar in diabetic (15.3% vs. 14.1%, respectively) and non-diabetic patients (9.7% vs. 8.9%, respectively). PCI was associated with a lower risk of stroke within the first year post-operation across all patients. Notably, diabetic patients underwent higher rates of spontaneous MI and repeat revascularization after PCI compared to CABG, with a more significant absolute excess risk observed beyond the first year compared to non-diabetic patients.

Implications for Practice: For patients with left main disease deemed suitable for either PCI or CABG, diabetes status significantly influences long-term outcomes, including death and cardiovascular events. While PCI offers a lower early risk of stroke, it is associated with increased risks of spontaneous MI and repeat revascularization, particularly in diabetic patients. These findings underscore the importance of considering patient-specific factors, such as diabetes status, in choosing between PCI and CABG for left main coronary artery disease revascularization.

Reference

Prakriti Gaba et al. (2024). Percutaneous Coronary Intervention Versus Coronary Artery Bypass Grafting in Patients With Left Main Disease With or Without Diabetes: Findings From a Pooled Analysis of 4 Randomized Clinical Trials. Circulation, 0. DOI: 10.1161/CIRCULATIONAHA.123.065571. Access the study here: Link


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